Falciparum Malaria Clinical Trial
Official title:
Phase Ib, Single-center, Randomized, Study to Determine Safety, Tolerability, and Pharmacokinetics of Different Orally Administered Regimens of the Combination ZY19489-Ferroquine in Adult Asymptomatic Plasmodium Falciparum Carriers
Malaria is caused by protozoan parasites of the genus Plasmodium and it is the most important parasitic disease in terms of mortality and morbidity. Estimates of 247 million malaria cases and 619.000 deaths worldwide were reported by WHO for the year 2021 (1). Plasmodium falciparum can lead to severe malaria and accounts for 90% of malaria deaths that mainly occur in children below the age of 5 years in Sub-Saharan Africa. A simplified treatment regimen, ideally a single-day cure (or at most 2-day dosing regimen), of uncomplicated malaria due to P. falciparum would be the magic in the antimalarial armamentarium. Improving treatment adherence is one of the key factors in reducing mortality and morbidity and also the transmission of malaria, and such a regimen would substantially increase adherence. To find a new non-artemisinin combination therapy with a shorter regimen, ideally, a single-dose cure, with low resistance potential would be the aim. The two compounds tested here are ZY19489, a triaminopyrimidine, and ferroquine (FQ), a next-generation 4-aminoquinoline. Both compounds show unique features in terms of long half-life, and activity against current drug-resistant strains. Therefore, the main goal of this clinical trial is to assess the safety of the ZY19489-FQ combination given as a 1- or 2-day dose regimen.
Total of 36 participants (3 cohorts with up to 12 participants each).The participant will receive the intervention orally once daily for one or two days, following a fasting period of at least 10 hours.Total duration of trial participation for each participant: Approximately 10 weeks (screening visits + 64 days of follow-up). ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00440752 -
The Impact of Artemether-Lumefantrine on Genes Associated With Antimalarial Resistance
|
N/A | |
| Completed |
NCT01144702 -
Effectiveness of the Association Artesunate and Mefloquine in the Treatment of Malaria by Plasmodium Falciparum
|
Phase 2/Phase 3 | |
| Terminated |
NCT00400101 -
Phase Ia Malaria Vaccine Trial of Two Virosome-Formulated Peptides
|
Phase 1 | |
| Completed |
NCT01350856 -
Tracking Resistance to Artemisinin (TRAC)
|
Phase 4 | |
| Completed |
NCT00859807 -
A Bioequivalence Study Comparing Camoquin® Suspension (Pfizer) To Flavoquine® Tablets (Sanofi Aventis) In Healthy Subjects
|
Phase 4 | |
| Completed |
NCT04222088 -
TES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014
|
||
| Completed |
NCT01115439 -
Artesunate+Sulfadoxine-Pyrimethamine for the Treatment of Uncomplicated Falciparum Malaria
|
N/A | |
| Completed |
NCT00282919 -
A Three Day Trial of Azithromycin Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria
|
Phase 2 | |
| Completed |
NCT04422015 -
Biological Mechanisms in Afebrile P. Falciparum Malaria
|
||
| Completed |
NCT00894374 -
Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
|
Phase 1 | |
| Completed |
NCT00894660 -
A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects
|
Phase 1 | |
| Completed |
NCT00493363 -
Clinical Investigation of In-vivo Susceptibility of P.Falciparum to Artesunate in Western Cambodia
|
N/A | |
| Completed |
NCT00158548 -
ACT With Chloroquine, Amodiaquine & Sulphadoxine-pyrimethamine in Pakistan
|
Phase 3 | |
| Withdrawn |
NCT04289558 -
Nitrite Infusion in Children With Malaria
|
Phase 1 | |
| Completed |
NCT01374126 -
Azithromycin Combination Therapy for the Treatment of Severe Malaria
|
Phase 2 | |
| Completed |
NCT00722150 -
Artemisinin Resistance in Cambodia II
|
N/A | |
| Completed |
NCT00157833 -
A Randomized Trial of Coartemether and Artekin for the Treatment of Uncomplicated Malaria in Papua, Indonesia.
|
N/A | |
| Completed |
NCT00513669 -
Phase Ib Trial of Two Virosome Formulated Malaria Vaccine Components (PEV 301, PEV 302) in Tanzania
|
Phase 1 | |
| Completed |
NCT00403260 -
Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria Patients
|
Phase 3 | |
| Completed |
NCT00442377 -
Study to Investigate the Induction of an Protective Immune Response to Malaria
|
N/A |